Key ResponsibilitiesConduct medical review of study related documentsPrepare high quality medical rationale documents for agency submissionPeriodic Safety reviewMedical monitoringDevelop clinical rationale for new products. Competencies and exposure to succeed in the role.Previous experience in medical review of clinical study documents (trial and BA/BE).Knowledge of clinical development for different regulatory such as USFDA, IND, EMA, JFDA.Familiarity
Key ResponsibilitiesConduct medical review of study related documentsPrepare high quality medical rationale documents for agency submissionPeriodic Safety reviewMedical monitoringDevelop clinical rationale for new products. Competencies and exposure to succeed in the role.Previous experience in medical review of clinical study documents (trial and BA/BE).Knowledge of clinical development for different regulatory such as USFDA, IND, EMA, JFDA.Familiarity
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